Clarifying Remanufacturing to Protect Patient Safety Act of 2022

Bill 117 HR 7253, also known as the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, aims to address concerns surrounding the remanufacturing of medical devices and equipment. The bill seeks to clarify the definition of remanufacturing in order to ensure that remanufactured medical devices meet the same safety and effectiveness standards as new devices.

Under the bill, remanufacturing is defined as the process of restoring a medical device to its original specifications or design. This definition is intended to distinguish remanufacturing from other processes such as refurbishing or repairing, which may not involve bringing the device back to its original state.

The bill also requires remanufacturers to comply with certain quality control and reporting requirements to ensure that remanufactured devices are safe for patient use. This includes maintaining records of the remanufacturing process, conducting testing to verify the safety and effectiveness of remanufactured devices, and reporting any adverse events related to remanufactured devices to the appropriate regulatory authorities. Overall, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022 aims to provide clarity and oversight to the remanufacturing process for medical devices in order to protect patient safety and ensure the quality of remanufactured devices.